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高效液相色谱法在法罗培南降解动力学分析中的应用

An application of high performance liquid chromatographic assay for the kinetic analysis of degradation of faropenem.

作者信息

Cielecka-Piontek J, Krause A, Paczkowska M

机构信息

Department of Pharmaceutical Chemistry, Faculty of Pharmacy, Poznan University of Medical Sciences, Poznań, Poland.

出版信息

Pharmazie. 2012 Nov;67(11):912-6.

Abstract

An isocratic RP-HPLC-DAD procedure was developed and validated for kinetic analysis of degradation of faropenem in bulk drug substance and in tablets. It involved the use of a C-18 analytical column (5 microm particle size, 250 mm x 4.6 mm), flow rate 1.3 ml/min and 50 microl injection volume. The mobile phase consisted of acetate buffer (pH 3.5) - acetonitrile (70:30 v/v). The determination was carried out at the wavelength of 323 nm. Kinetic studies of faropenem degradation in aqueous solutions included hydrolysis, oxidation, photolysis and thermal degradation. A derivative spectrophotometry was used as an alternative method to compare the observed rate constants.

摘要

开发并验证了一种等度反相高效液相色谱-二极管阵列检测法,用于原料药和片剂中法罗培南降解的动力学分析。该方法使用C-18分析柱(粒径5微米,250毫米×4.6毫米),流速1.3毫升/分钟,进样体积50微升。流动相由醋酸盐缓冲液(pH 3.5)-乙腈(70:30 v/v)组成。测定在323纳米波长下进行。法罗培南在水溶液中的降解动力学研究包括水解、氧化、光解和热降解。采用导数分光光度法作为替代方法来比较观察到的速率常数。

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